FDA 510(k)

EndoFLIP® 系統搭配 FLIP 地形模組

K 號：K170833 · 2017-04-17

決定日期2017-04-17

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

EndoFLIP® System with FLIP Topography module is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K170833. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoFLIP® System with FLIP Topography module?

EndoFLIP® System with FLIP Topography module is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Crospon, Ltd.. The 510(k) number is K170833.

When did EndoFLIP® System with FLIP Topography module receive FDA 510(k) clearance?

EndoFLIP® System with FLIP Topography module received FDA 510(k) clearance on 2017-04-17, under 510(k) number K170833.

Who is the listed applicant for EndoFLIP® System with FLIP Topography module?

The FDA 510(k) record lists Crospon, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoFLIP® System with FLIP Topography module?

The FDA product code for EndoFLIP® System with FLIP Topography module is FFX.

其他以 Crospon, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：FFX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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